S/he may participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed.

S/he may provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.

Prepares clinical documents, business correspondence, and procedural manuals. Maintain systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory- compliant clinical projects are conducted on time and within budget.

Depending upon the level of experience, may become involved, when required, in other areas of study management and staff training and contributes to the review of sponsor/client’s and/or FHI360’s systems and procedures as appropriate.

Accountabilities:

Assists in the preparation of routine protocols, informed consents, SOPs, and other appropriate documentation.

Monitors clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations and ICH/GCP Guidelines, may be done with supervisor.